Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06935851
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-20
First Post:
2024-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Word Characteristics and Orthography on Vocabulary Learning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-17', 'size': 24956, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-17T13:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-12', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2025-04-12', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total number of words learned to criterion', 'timeFrame': '12 weeks', 'description': 'Is there a significant difference in the total number of words learned to criterion comprehension, recognition, production, spelling recognition, and spelling production?'}], 'primaryOutcomes': [{'measure': 'Pre- and post test total correct scores', 'timeFrame': 'up to 12 weeks', 'description': "Is there a significant difference in pre- and post test total correct scores for different word types with mother's education level covaried as measured by comprehension, recognition, production, spelling recognition and spelling production."}], 'secondaryOutcomes': [{'measure': 'Number of trials to criterion', 'timeFrame': 'up to 8 weeks', 'description': 'Is there a significant difference in the number of trials to criterion required to learn a new word for different word types as measured by comprehension, recognition, production, spelling recognition and spelling production?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Developmental Child Delay']}, 'referencesModule': {'availIpds': [{'url': 'https://osf.io', 'type': 'Study Protocol', 'comment': 'signing a data agreement'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to investigate how word characteristics (e.g., phonotactic probability) and orthography affect vocabulary by children with low oral language levels. The investigators will use a 2 x 2 within-subjects factorial design where every participant receives the treatment. This 12-week study aims to improve vocabulary learning efficiency for children with low oral language levels. The study's findings will uniquely contribute to the field in that this is the first research study using real words instead of nonwords while combining word learning research with vocabulary learning.", 'detailedDescription': 'The investigators are proposing a vocabulary intervention that analyzes word sounds and sound segments. This analysis offers valuable insights into how children at risk for specific learning disabilities, such as dyslexia or speech and language impairments, learn words differently from typically developing children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nScore of 85 or lower on the Clinical Evaluation of Language Fundamentals - CELF (4) Enrolled in or just completed third grade.\n\nExclusion Criteria:\n\nAny diagnosis of sensory impairments A diagnosis of autism or traumatic brain injury'}, 'identificationModule': {'nctId': 'NCT06935851', 'acronym': 'VOCAL+', 'briefTitle': 'Effect of Word Characteristics and Orthography on Vocabulary Learning', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'The Effect of Word Characteristics and Orthography on Vocabulary Learning', 'orgStudyIdInfo': {'id': 'STUDY00020728'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single group Assignment', 'description': 'There are no subgroups in this study. All participants will receive the intervention.', 'interventionNames': ['Behavioral: VOCAB +']}], 'interventions': [{'name': 'VOCAB +', 'type': 'BEHAVIORAL', 'description': 'The purpose of the study is to investigate how word characteristics (e.g., phonotactic probability) and orthography effect vocabulary learning by children with low oral language levels. We will be using a 2 x 2 within-subjects factorial design where every participant serves as their own control. This 12-week study aims to improve the Efficiency of vocabulary learning for children with low oral language levels.\n\nThe four interventions that are all participants will be exposed to are the following: high pp words with orthography; high pp words without orthography; low pp words with orthography; low pp words without orthography.', 'armGroupLabels': ['Single group Assignment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Osborn District School Encanto', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': "The data will be made available within 7 months of the study's conclusion and will remain available for at least 5 years.", 'ipdSharing': 'YES', 'description': '* Study Protocol\n* Statistical Analysis Plan (SAP)\n* Informed Consent Form\n* Clinical Study Report', 'accessCriteria': 'Signing a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mariana Silva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arizona State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctoral Student', 'investigatorFullName': 'Mariana Silva', 'investigatorAffiliation': 'Arizona State University'}}}}